Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

June 22, 2026 updated by: Firalis SA

Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis

Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests measure in blood and other peripheral body fluids; long non-coding RNAs (lncRNAs), small non-coding RNAs (sncRNAs), messenger RNAs (mRNAs), circulating proteins, lipids and metabolites. In addition, since 2020, Firalis is producing the salivary test EasyCOV for detection of Covid-19 positivity in both symptomatic and asymptomatic subjects. Firalis group is the sponsor of a pipeline of various clinical studies conducted in diverse National and European clinical sites of excellence, enrolling patients affected by the targeted diseases studied such as acute myocardial injury, Alzheimer disease for the proof of performance phase of the biomarkers and IVD test candidates. The present specific study aims to collect biological samples to complete the analytical validation of its diverse IVD tools namely the evaluation of the stability of the biomarkers and the effect of age, gender, nutrition and inter-period on the expression level of the studied biomarkers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Huningue, France, 68330
        • Recruiting
        • Firalis Clinical Investigation Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants who sign the informed consent forms for sample collection and data collection both anonymized and reported in CRF.
  • Able to comply with all study procedures.
  • Healthy Volunteers having no apparent disease.
  • Adults, both genders, aged 18-85 years.
  • Participants with no apparent motor or mental health abnormality.
  • Participants having no major disabling mental or physical disability that would require hospitalization.
  • Body weight above 50 kg if male, above 40 kg if female.

Exclusion Criteria:

  • Any subject who did not sign the Informed Consent form.
  • Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development.
  • Any subject in the exclusion period of a previous study according to applicable regulations.
  • Any subject who cannot be contacted in case of emergency.
  • Any subject who is the Investigator or any sub-investigator, research assistant, study coordinator, or other staff thereof, directly involved in the conduct of the protocol.
  • Any subject with a disease that, in the judgement of the investigator, would interfere with the conduct of study or harm the safety of volunteer.
  • Subjects with disabling disease or abnormal health status are excluded.
  • Subjects aged below 18 years and older than 85 years are excluded.
  • Pregnant, parturient and nursing women are excluded.
  • Subjects deprived of their liberty by a judicial or administrative decision, protected adults and vulnerable persons are excluded.
  • Subjects who are under legal protection or who are unable to express their consent are not included.

  • Any subject who reports in the questionnaire of the screening period having one of the following diseases is excluded:

    • Any psychiatric or neurodegenerative disease or neurologic disorder.
    • Hypertension.
    • Any cardiovascular disease.
    • Any chronic inflammatory disease such as rheumatoid arthritis.
    • Any cancer.
    • Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
  • Any subject who did a blood donation, any volume, within 2 months before inclusion.
  • Any subject who reports in the questionnaire of the screening period having medication(s) for one or more of the above diseases is excluded.
  • Drug or alcohol abuse or smoking more than 10 cigarettes or equivalent.
  • Subjects with no apparent disease and symptoms, but with unknown Covid-19 positivity are not excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Healthy Volunteers
Healthy Volunteers will be recruited into the study
Diagnostic test: Biomarker based IVD tests
Biomarker based IVD tests

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
lncRNA Biomarker expression before breakfast intake
Time Frame: T0- Baseline in the morning before breakfast at fasting conditions
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
T0- Baseline in the morning before breakfast at fasting conditions
lncRNA Biomarker expression after breakfast intake
Time Frame: T1- 1 hour after breakfast
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
T1- 1 hour after breakfast

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sncRNA Biomarker expression before breakfast intake
Time Frame: T0- Baseline in the morning before breakfast at fasting conditions
sncRNA cycle threshold measured in blood plasma
T0- Baseline in the morning before breakfast at fasting conditions
sncRNA Biomarker expression after breakfast intake
Time Frame: T1- 1 hour after breakfast
sncRNA cycle threshold measured in blood plasma
T1- 1 hour after breakfast
mRNAs Biomarker expression before breakfast intake
Time Frame: T0- Baseline in the morning before breakfast at fasting conditions
mRNAs cycle threshold measured in blood plasma
T0- Baseline in the morning before breakfast at fasting conditions
mRNAs Biomarker expression after breakfast intake
Time Frame: T1- 1 hour after breakfast
mRNAs cycle threshold measured in blood plasma
T1- 1 hour after breakfast
Soluble proteins Biomarker expression before breakfast intake
Time Frame: T0- Baseline in the morning before breakfast at fasting conditions
Soluble proteins expression in ng/mL measured in blood plasma
T0- Baseline in the morning before breakfast at fasting conditions
Soluble proteins Biomarker expression after breakfast intake
Time Frame: T1- 1 hour after breakfast
Soluble proteins expression in ng/mL measured in blood plasma
T1- 1 hour after breakfast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Firalis SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Rohrlich, MD,Phd, Firalis SA
  • Study Director: Hueseyin Firat, MD, PhD, HDR, Firalis SA
  • Study Chair: Stephanie Boutillier, PhD, Firalis SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-A00405-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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